Model note · Colonoscope
PENTAX Medical i10 EC38-i10L video colonoscope
The EC38-i10L is PENTAX Medical's routine HD+ colonoscope with a 3.8 mm channel and water jet, in long, medium and other lengths. Like the EG scopes it has an insertion portion with bending section, a control body with valves and an umbilical cord ending in a PVE connector to the video processor. It is widely used and heavily represented in MAUDE.
The model
Maker, model and type.
- Maker
- HOYA Corporation, PENTAX Medical
- Model
- EC38-i10L video colonoscope
- Device type
- Colonoscope
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Distal end diameter | 13.2 mm | Source |
| Instrument channel | 3.8 mm | Source |
| Working length (L version) | 1,700 mm | Source |
| Field of view | 140 degrees | Source |
| Tip deflection | Up/down 180/180, right/left 160/160 degrees | Source |
| Features | HD+ chip, water jet system | Source |
| FDA clearance | K131855 (EC family), product code FDF | Source |
Recalls
Known FDA recalls.
- Z-2448-20212021-07-14
Updated reprocessing IFUs for EC scopes with one instrument channel and a water jet channel, including EC38-i10L.
FDA record - Z-1268-20202020-01-03
One EC38-i10L unit distributed in the US without an approved 510(k).
FDA record
Sources
Where this note comes from.
- FDA 510(k) K131855 summary, PENTAX Video Colonoscopes (EC family)
- PENTAX Medical Europe product overview, 2014 (copy hosted by a distributor)
- FDA recall Z-2448-2021, PENTAX EC reprocessing IFU update
- FDA recall Z-1268-2020, EC38-i10L
- openFDA MAUDE problem counts, model EC38-i10L
Not covered: PENTAX manuals are behind a login, so no error codes, leak test details or service intervals are given. Specifications are from a 2014 PENTAX Europe brochure on a distributor site; the insertion tube diameter did not extract cleanly and is left out. The PENTAX website could not be read automatically.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Colonoscope